Kornimate/medical-research-clean huggingface dataset:
pure fish oil parenteral lipid emulsion in patients with gastrointestinal cancer

Conditions: Surgery

Summary: surgical trauma can lead to an intense inflammation and impairment of the capacity to fight against infections. fish oil is composed by substances called omega-3 fatty acids which have anti-inflammatory effects. when infused through the vein as part of a nutritional treatment of some surgical patients, fish oil have been shown to preserve some defense capabilities against infections and to decrease postoperative release of inflammatory substances, contributing to the shortening of length of hospital and intensive care unity (icu) stay and complications, mainly infectious complications. these reported benefits have been encouraging the vein infusion of fish oil as a kind of medicine to contribute for the treatment of surgical patients. in current study the investigators evaluated the effect of preoperative infusion of pure fish oil in patients with gastrointestinal cancer (stomach and colon) on their clinical outcomes. the hypothesis considered that preoperative infusion of fish oil, not as part of nutritional therapy but as a medicine agent, can attenuates inflammation and improves the capacity of surgical patients to fight against infections, improving their treatment.


Eligibility criteria:
inclusion criteria: elective surgical patients with confirmed (biopsy) gastrointestinal (colon or stomach) cancer; 30-75 years old; venous assess to blood collections (40 ml) to receive parenteral infusions of lipid emulsion; karnofsky performance statuses of ≥60 exclusion criteria: intolerance or allergy to any ingredient in lipid emulsion; diagnosis of infectious, inflammatory, immunologic or metabolic diseases; dementia;medicine intake that could significantly modulate metabolism; implanted electromagnetic instruments.

Keywords: fish oil omega-3 fatty acids parenteral lipid emulsions immune response surgery
belgian prospective multicentre registry on the performance of the smart stent in the superficial femoral artery according to the new tasc ii-classification

Conditions: Peripheral Vascular Disease

Summary: this is a belgian prospective multicentre registry on the performance of the smart stent in the superficial femoral artery according to the new tasc ii-classification.


Eligibility criteria:
inclusion criteria: * stenosis (\> 75%) or occlusion of the superficial femoral artery (lesion up to 3 cm distal to hunter's canal) * new tasc (2007) a, b, or c lesions * vessel diameter between 4.5 and 6.5 cm * debilitating claudication or critical limb ischemia (rutherford 2 to 5) * at least 1 outflow vessel down to the ankle * signed informed consent * \> age 50, life expectancy \> 1 year * capable of concluding the necessary follow-up visits exclusion criteria: * refusal to participate in the study * acute ischemia * inflow lesions \> 50%, not successfully corrected before the procedure * combination with other treatment with the exception of treatment to improve the inflow

Keywords: stenosis (> 75%) or occlusion of the superficial femoral artery
study to assess change in disease activity and adverse events of oral venetoclax in combination with intravenous (iv) obinutuzumab or oral ibrutinib in adult participants with untreated chronic lymphocytic leukemia (cll)/small lymphocytic lymphoma (sll)

Conditions: Chronic Lymphocytic Leukemia (CLL); Small Lymphocytic Lymphoma (SLL)

Summary: chronic lymphocytic leukemia (cll) is the most common leukemia in western countries, representing approximately 30% of all adult leukemias. there is a large difference in proportion of malignant lymphoma between the united states (us) and japan was seen in cll/small lymphocytic lymphoma (sll) (japan, 3.2%; us, 24.1%). the purpose of this study is to assess how well venetoclax works in combination with obinutuzumab (v+g, cohort 1) or with ibrutinib (v+i, cohort 2) in japanese participants with previously untreated cll/small lymphocytic lymphoma (sll). adverse events and change in disease activity will be assessed. venetoclax is an approved drug for the treatment of cll and sll. study doctors put the participants in 1 of 2 groups, called treatment arms, based on variable alternating assignment. approximately 20 adult participants with previously untreated cll/sll will be enrolled in the study in approximately 20 sites in japan. participants in group 1 will receive oral venetoclax + intravenous (iv) obinutuzumab (v+g) in 28-day cycles for a total of 12 cycles, and participants in group 2 will receive oral venetoclax + oral ibrutinib (v+i) in 28-day cycles for a total of 15 cycles. there may be higher treatment burden for participants in this trial compared to their standard of care. participants will attend regular visits during the study at a hospital or clinic. the effect of the treatment will be checked by medical assessments, blood tests, and checking for side effects.


Eligibility criteria:
inclusion criteria: * adult male or female, at least ≥ 65 years old; or 20 to 64 years old and have at least 1 of the following: * cumulative illness rating scale (cirs) score \> 6. * creatinine clearance (crcl) estimated \< 70 ml/min using cockcroft-gault equation. * must have measurable nodal disease (by computed tomography \[ct\]), defined as at least one lymph node \> 1.5 cm in longest diameter. * diagnosed chronic lymphocytic leukemia (cll)/small lymphocytic lymphoma (sll) that requires treatment according to the modified 2008 international workshop on chronic lymphocytic leukemia (iwcll) criteria. exclusion criteria: * transformation of chronic lymphocytic leukemia (cll) to aggressive non-hodgkin lymphoma (nhl; richter's transformation or pro-lymphocytic leukemia). * previous treatment history for cll/sll.

Keywords: chronic lymphocytic leukemia (cll) small lymphocytic lymphoma (sll) ibrutinib imbruvica venetoclax venclexta venclyxto obinutuzumab ga101 gazyva ro5072759
barriers to peritoneal dialysis selection

Conditions: Chronic Kidney Disease

Summary: the purpose of this study is to understand what prevents chronic kidney disease patients from making a timely decision about dialysis modality options. this understanding will allow us to develop and implement interventions to assist patients in this turning point so that they can make the right decision for them in a timely enough manner so that each patient can start dialysis in the safest and best way for them. 200 later stage chronic kidney disease patients (20% or less of kidney function remaining) will be asked to participate in the study with the goal of having 150 patients participate in the study. hypotheses: 1. 50 % of patients will have made a modality decision when interviewed and patients in the action stage of behavior will be more likely to make a modality selection than patients in earlier stages of behavior change. barriers to modality selection will act at several levels including patient, provider and health system level and will vary by behavioral stage of change 2. 10-15% of patients might choose home dialysis. knowledge, self efficacy in terms of ckd, education, and income will likely be barriers to home dialysis choice.


Eligibility criteria:
inclusion criteria: * all patients of age greater than or equal to 18 years at mhmc who are late stage ckd exclusion criteria: * patients who have acute renal failure and then recover renal function to levels of egfr (estimated glomerular filtration rate) 20 ml/min/1.73m2 and in whom the nephrologist feels will not progress to esrd in 2 years * patients who are not candidates for peritoneal dialysis * pregnant women

Keywords: peritoneal dialysis modality choice kidney disease
efficacy and safety of d-chiro-inositol in obese patients

Conditions: Insulin Resistance

Summary: the study aims to evaluate the efficacy and tolerability of a food supplement based on d-chiro-inositol in overweight or obese women with insulin resistance, who are approaching a hypocaloric diet

scientific studies on overweight/obese non-diabetic subjects have shown that weight loss improves insulin sensitivity. in fact, in these subjects weight loss reduces the insulin response to the oral glucose load and lowers plasma concentration of triglycerides. however, although the insulin value is reduced with diet, it does not reach the levels found in overweight/obese non-insulin resistant subjects. it has been shown that the supplementation of d-chiro-inositol (dci), a polyol with an insulin-sensitizing action, can positively affect insulin resistance, avoiding the typical side effects of classic insulin sensitizers. in fact, dci improves glucose tolerance and increases insulin sensitivity, as demonstrated in hyperinsulinemic women with polycystic ovary syndrome. therefore, considering the role of dci, we want to investigate the efficacy and tolerability of a dci-based product in overweight / obese women with insulin resistance who are approaching a low-calorie diet.

Eligibility criteria:
inclusion criteria: * women between 25 and 40 years old * diagnosis of insulin resistance (homa ≥2.5) * 26≤ bmi ≤32 exclusion criteria: * subjects with no indication for treatment * pregnancy and breastfeeding * treatment with drugs or supplements that interfere with the mechanism of action of insulin
an efficacy and safety study of anti-tnf monoclonal antibody in patients with fistulizing crohn's disease

Conditions: Crohn Disease

Summary: the purpose of this study is to evaluate the effectiveness and safety of anti-tnf chimeric monoclonal antibody (ca2) compared to placebo in the treatment of patients with fistulizing crohn's disease.

this is a randomized, placebo-controlled, double-blind, repeated-dose study to evaluate the effectiveness and safety of anti-tnf chimeric monoclonal antibody (ca2) compared to placebo in the treatment of patients with fistulizing crohn's disease. the primary efficacy outcome of the study is the number of patients with at least a 50% reduction from baseline in the number of open fistulae observed for at least two consecutive evaluation visits. patients will be treated with either anti-tnf chimeric monoclonal antibody (ca2) or matching placebo.

Eligibility criteria:
inclusion criteria: * patients with crohn's disease of at least 3 months duration confirmed by radiography orendoscopy * having single or multiple draining enterocutaneous (including perianal) fistulae of at least 3 months duration * if treated with oral prednisone (or equivalent), the dose must be \<=40 mg/day and must have been stable for at least 3 weeks prior to enrollment. (if currently not treated with oral prednisone, the stop date must have been at least 4 weeks prior to enrollment) * if treated with 6-mercaptopurine or azathioprine, the start date must have been at least 6 months prior to enrollment. (the dose must have been stable for at least 8 weeks prior to enrollment. if currently not treated with 6-mercaptopurine or azathioprine, the stop date must have been at least 4 weeks prior to enrollment.) exclusion criteria: * patients with local complications of crohn's disease such as strictures or abscesses that might confound the evaluations of the benefit from ca2 treatment * having abscesses that should be drained prior to enrollment, with at least 3 weeks between drainage of the abscess and enrollment * having a serious infection, such as hepatitis, pneumonia or pyelonephritis, in the previous 3 months or a history of opportunistic infection such as herpes zoster within 2 months prior to screening, or evidence of active cytomegalovirus, active pneumocystis carinii, or drug resistant atypical mycobacterium * currently having signs or symptoms of severe, progressive or uncontrolled renal, hepatic, hematologic, endocrine, pulmonary, cardiac, neurologic or cerebral disease * currently having any known malignancy or any history of malignancy within the past 5 years

Keywords: fistulae crohn's disease
to assess the level of adherence of subjects receiving saizen® via easypod™ in argentina

Conditions: Growth Disorders

Summary: this is an argentinian, multicentre, observational study to evaluate adherence and long term outcomes of therapy in paediatric subjects using easypod™ electromechanical device for growth hormone treatment and to assess the level of adherence of subject receiving saizen® via easypod™.

subjects will be enrolled in a multicenter longitudinal observational study. parents/subjects will provide their informed consent/assent to upload their data for population-based analyses and, ultimately, clinical outcomes. adherence data will be primarily derived from the easypod™ device combined with physician data entry of outcome measures. data will be collected both retrospectively and prospectively. this will allow the establishment of adherence profiles and explore the hypothesis that patient adherence support programs improve adherence and subsequent clinical outcomes. collected data will be also analyzed in a multinational pooled analysis of comparable national studies. primary objective: • to assess the level of adherence of subjects receiving saizen® via easypod™ secondary objectives: * to describe the impact of adherence on clinical outcomes for subject receiving saizen® via easypod™ * to identify adherence subject profiling * to assess the impact of adherence on insulin-like growth factor 1 (igf1) (i.e. above, below or within normal ranges)

Eligibility criteria:
inclusion criteria: * administered growth hormone via the easypod™ electromechanical device according to summary of product characteristic (smpc) * over the age of \>2 years * under \<18 years of age, or over 18 without fusion of growth plates * parent's or guardian's written informed consent, given before entering data into the observational study, with the understanding that the subject or parent/guardian may withdraw consent at any time without prejudice to future medical care. if the child is old enough to read and write, a separate assent form will be given as defined in the appropriate jurisdiction of each country exclusion criteria: * subjects taking growth hormone in whom growth plates have fused (i.e. for taking growth hormone for it's metabolic effects) * contra-indications to saizen® as defined in the smpc * use of an investigational drug or participation in another interventional clinical study

Keywords: growth disorders saizen easypod growth hormone pediatric subject
a randomized controlled study of ablation pursuing atrial fibrillation termination as a procedural endpoint in patients with persistent atrial fibrillation

Conditions: Atrial Fibrillation; Cathter Ablation; Endpoint

Summary: this is a prospective, randomized, multi-center trial that aims to investigate whether termination of atrial fibrillation can be used as an ablation endpoint for persistent atrial fibrillation (persaf). eligible patients who provided consent were randomly assigned to one of two groups: the af-termination group (whose ablation endpoint was the pursuit of af-termination) or the prespecified-ablation group (whose ablation endpoint was prespecified ablation followed by electrical cardioversion).


Eligibility criteria:
inclusion criteria: 1. . age 18-80 years old. 2. . patients undergoing a first-time ablation procedure for persaf. 3. . diagnosed as persistent af according to the latest clinical guidelines. 4. . ineffective or intolerable to ≥1 anti-arrhythmia drug treatment. 5. . patients must be able and willing to provide written informed consent to participate in this study. exclusion criteria: 1. . uncontrolled congestive heart failure; 2. . history of severe valve disease and/or prosthetic valve replacement; 3. . myocardial infarction or stroke within 6 months; 4. . severe congenital heart disease; 5. . ef \<35%; 6. . contrast agent allergy; 7. . the use of anticoagulant drugs is contraindicated; 8. . severe lung disease; 9. . left atrial thrombus confirmed by preoperative esophageal ultrasound; 10. . contraindications for cardiac catheterization; 11. . prior left atrial ablation (surgical or catheter); 12. . have performed any cardiac surgery within 2 months; 13. . poor general health; 14. . life expectancy \< 12 months.
evaluation of metionac for the modulation of metabolic and endocrine parameters in patients with pcos.

Conditions: Polycystic Ovary Syndrome

Summary: evaluate the efficacy of the combination of antioxidants ala, nac, vit. b6 and same as a dietary supplement, in the improvement of metabolic and endocrine parameters and clinical manifestations of pcos.

the investigators will explain the study to all patients who meet the inclusion and exclusion criteria during the study period. after signing the informed consent patients will be randomized 1:1 to oral contraceptive 4 mg drospirenone once daily or oral contraceptive 4 mg drospirenone + combination of 200 mg s-adenosylmethionine, 100 mg n-acetylcisteine, 75 mg alpha lipoid acid and 0,65 mg vitamin b6 (metionac) twice daily. patients for whom oral contraceptive is not indicated will be enrolled in third study group of metionac twice daily. 2 study visits will be carried out, baseline (visit 0) and after 6 months therapy (visit 1).

Eligibility criteria:
inclusion criteria: 1. women newly diagnosed with pcos with at least 2 of the following symptoms: * oligo/anovulation \ 35 days \> 90 days (any cycle) \< 8 periods / year * hyperandrogenism (clinical symptoms or laboratory results) * polycystic ovary morphology (nhmrc guideline): in any ovary: 20 follicles\* and/or ovarian volume greater than or equal to 10ml and no corpus luteum, cysts or dominant follicles \*number of follicles per ovary measuring 2-9 mm 2. \> 18 years old 3. overweight defined as bmi\>25 4. normal prolactin levels 5. women with altered coagulation factors or a personal history of thromboembolism for whom oac is contraindicated (they will be included in the control group without randomization) 6. written inform consent exclusion criteria: 1. diabetic women 2. adrenal enzyme deficiency and/or other endocrine disease 3. pregnant or lactating women. 4. women under treatment with snris (serotonin reuptake inhibitors) 5. other serious illness
weight approximation in stroke before thrombolysis

Conditions: Stroke

Summary: thrombolysis using alteplase (tpa) is still the only approved specific therapy for acute ischemic stroke (ais). current guidelines in western countries recommend an tpa dose of 0.9mg/kg up to a maximum dose of 90mg for patients weighing more than 100kg. however, larger dose-finding rtpa trials for intravenous thrombolysis in ais are missing. based on results from research on myocardial infarction only a few open label studies with low case rates were initiated to evaluate the optimal dose for tpa in cerebral ischemia. these studies suggested a narrow therapeutic range with decreased efficacy in lower dosages and an increased risk for thrombolysis related intracerebral hemorrhage (ich) at doses above 0.95mg/kg. the ecass-1 trial which used a dosage of 1.1mg/kg rt-pa showed significantly higher rate of large parenchymal hemorrhages compared to trials using 0.9mg/kg. therefore accurate dosing is crucial. in the acute phase two aspects complicate rtpa dosing in ais: first, unlike in other diseases many stroke patients are unable to communicate information on their body weight (bw) because of their stroke symptoms (e.g. aphasia, decreased consciousness). in addition motor symptoms prohibit easy weighing procedures in many patients. second, the ultra-early and narrow time window for treatment does not allow time loss to weigh each patient in the emergency situation. therefore routinely the attending physician has to make a visual estimation of the patient's bw. this may be inaccurate and may cause dosing errors which has been shown for other weight based emergency medication. there is little data on tpa-dosing errors in stroke patients and prospective data are lacking. the aim of our study is to evaluate availability of bw-information, accuracy of estimations and final dosing of tpa in a routine clinical setting. therefore the investigators evaluate different sources of body weight estimations and also compare visual estimation with recently proposed anthropometric measurements for body weight approximation. finally, impact of dosing errors on safety and efficacy are analyzed. the initial phase will consist of 100 enrolled patients as a pilot phase for further power calculations. based on the results of the pilot phase enrollment will continue. the envisioned inclusion target is up to 800 patients.


Eligibility criteria:
inclusion criteria: * all patients receiving intravenous thrombolysis with tpa for acute ischemic stroke exclusion criteria: * common exclusion criteria for intravenous thrombolysis

Keywords: stroke thrombolysis
hemothorax caused by posterior correction surgery for spinal deformity

Conditions: Spinal Deformity; Hemothorax Postoperative

Summary: owing to the development of instruments and surgical techniques, the number of spinal deformity correction surgeries has increased significantly. the incidence of hemothorax due to posterior correction surgery for spinal deformity is reported to be as low as 0.1%, and the vast majority of these cases were treated through observation without additional intervention. however, if hemothorax that occurs is missed, it can result in increased mortality and morbidity. furthermore, there is a paucity of data on management of hemothorax caused by posterior correction surgery. the aim of this retrospective study is to evaluate our cases of hemothorax after posterior correction surgery for spinal deformity.

we retrospectively reviewed medical records of all pediatric patients who underwent posterior correction surgery from 2016 to 2021.

Eligibility criteria:
inclusion criteria: * children who underwent posterior correction surgery for spinal deformities (age range 1-18 years) exclusion criteria: -

Keywords: spinal deformity posterior correction surgery hemothorax
anatomical and functional macular changes in retinal detachment

Conditions: Rhegmatogenous Retinal Detachment

Summary: the purpose of this study is to evaluate the correlation between morphologic changes in the outer retina and visual function after successful repair of rhegmatogenous retinal detachment with macula off.


Eligibility criteria:
inclusion criteria: * rhegmatogenous retinal detachment exclusion criteria: * epiretinal membrane

Keywords: retina rhegmatogenous retinal detachment macular detachment spectral domain oct microperimetry